Ever-Soft Positioning Wedge
- Primary DI
- 00616784300344
- Brand
- Ever-Soft Positioning Wedge
- Company
- DYNAREX CORPORATION
- Model
- 13003
- Device description
- Positioning Wedge 8"x8"x35" 45 Degrees
- Published
- 2021-04-22
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| IMP | Cushion, Wheelchair |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| IMP | Cushion, Wheelchair | Physical Medicine | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00616784300344 | Package | GS1 | 2 | In Commercial Distribution |
| 00840117307766 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00616784300344 | 00616784300344 | 616784300344 | 0616784300344 |
| 00840117307766 | 00840117307766 | 840117307766 | 0840117307766 |
GMDN Terms
| Term | Definition |
|---|
| Assistive sleeping cushion set | A collection of cushions, pads, pillows and bolsters intended to provide support and optimal positioning for a disabled person during sleep. The items are typically made of soft textile or synthetic materials and include pieces designed for specific body parts (e.g., head, shoulders, back, hips, knees, feet) used during different sleeping positions (supine, side, or prone lying). This is a reusable device. |
Regulatory Flags
- DUNS number
- 008124539
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
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